Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial

Not Applicable

Withdrawn

• Conditions: Infant, Premature; Hypothermia, Newborn
• Interventions: Other: Cardboard Cot Care; Other: Incubator Care

• Registration Number: NCT03344978
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

This study will determine whether the efficacy of Mylar-lined cardboard cots is equivalent to traditional incubators in their ability to prevent hypothermia (axillary temperature \< 36° C) in preterm neonates \<36 6/7 weeks gestational age in a randomized cross-over designed trial. Infants will be randomized to receive care in the cardboard cot or incubator and then cross over to the other device for 24 hour periods, rotating for a total of 96 hours total trial time.

Detailed Description

The aim of the trial is to determine whether a corrugated cardboard cot will assist in maintaining infant axillary temperatures comparing it to the temperatures of the same infant being nursed in low heat incubators. The study will be done in the context of standard medical care, including the WHO thermoregulation protocol (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling).

The cardboard cot is approximately 24 inches long to accommodate the length of the infant and about 12 inches wide to accommodate term infants, even beyond the first months after birth. The cots are fully lined with a reflective metallized film sheet of Mylar. The cot will be covered with a cardboard piece also lined in reflective film up to about the infant's shoulders so that the infant's face is visible. Attached to the lid is a 5 inch cardboard flap lined with reflective film which folds down into the body of the cot to reduce heat loss.

Infants ≤ 36 6/7 weeks gestation will be randomized to receive care in a cardboard cot or an incubator. Infants will begin care in one device and after 24 hours will cross over to the other device for another 24 hours. The process will be repeated once more for a total of 96 hours of study duration. The infants will be normothermic and stable when they are enrolled in the trial. Axillary temperatures will be measured at 1 hr, 6 hours and 24 hours after being placed in the cost or incubator. Infants with observed hypothermia (\<36° C) will have measures taken to increase temperature (i.e. adding blankets, hat).

Study Timeline

• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Study Start: 2019-06-11
• Primary Completion: 2021-09-27
• Study Completion: 2021-09-27
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Estimated gestational age < 36 6/7 weeks
• Hospitalized in the NICU at University Teaching Hospital in Zambia
• Requiring incubator/radiant warmer for at least 1 week

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Exclusion Criteria

• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder
• Suspected Sepsis
• Requiring ongoing respiratory support

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cardboard Cot Care	Cardboard Cot Care	Stable infant will be nursed in a cardboard cot, lined with reflective film for 24 hour period of time. Infant's axillary temperature will be taken at 1 hour after randomization, at 6 hours after randomization, and 24 hours after randomization. After 24 hours, infant will be swapped to the other arm (Incubator Care), and back for a total of 2 24-hour periods in each arm.
Incubator Care	Incubator Care	Stable infant will be nursed in an incubator for 24 hour period of time. Infant's axillary temperature will be taken at 1 hour after randomization, at 6 hours after randomization, and 24 hours after randomization. After 24 hours, infant will be swapped to the other arm (Cardboard Cot Care), and back for a total of 2 24-hour periods in each arm.

Primary Outcome Measures

Name	Time	Method
Moderate (32.-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature	1 hour after placement in warming device	Temperature taken via axilla for 1 minute duration
Moderate (32.0-35.9° C) or Severe (<32.0° C) hypothermia per Axillary Temperature	6 hours after placement in warming device	Temperature taken via axilla for 1 minute duration
Moderate (32.-35.9° C) or Severe (<32.0°C) hypothermia per Axillary Temperature	24 hours after placement in warming device	Temperature taken via axilla for 1 minute duration

Secondary Outcome Measures

Name	Time	Method
Normothermia (Axillary temperature 36.0 - 38.0° C)	1-96 hours after beginning of study	Temperature taken via axilla for 1 minute duration
Rate of Severe hypothermia (<32.0° C) after placement in warming device	24 hours after placement in warming device	Temperature taken via axilla for 1 minute duration
Rate of Moderate hypothermia (32.0-35.9° C) after placement in warming device	24 hours after placement in warming device	Temperature taken via axilla for 1 minute duration
Rate of Hyperthermia (>38.0°C) after placement in warming device	4 months	Temperature taken via axilla for 1 minute duration
Hypothermia (Axillary temperature < 36.0° C)	1-96 hours after beginning of study	Temperature taken via axilla for 1 minute duration
Mean Axillary Temperature in each device	4 months	Average of all axillary temperatures taken per device
Rate of Moderate hypothermia (32.0-35.9°C) after placement in warming device	6 hours after placement in warming device	Temperature taken via axilla for 1 minute duration